Quality Engineer II

About the company:

Viant is a global medical device partner providing design, development, manufacturing, and assembly services through capabilities in materials, plastics, metals, extrusion, and automation. With nearly 6,000 employees across 24 locations worldwide, it delivers high-quality, life-enhancing products with the scale and expertise to bring devices to market efficiently. Learn more at Viant Medical's website or on Linked In.
About the site:
Our Wheeling facility focuses on precision machining of metal components, supporting high-performance medical device manufacturing.

About the role:

As a Quality Engineer II, you will provide hands-on quality engineering support directly on the manufacturing floor for medical device operations. This role requires a strong presence in the production environment, partnering closely with operators, supervisors, and manufacturing engineers to resolve real-time quality issues, support inspection activities, and ensure adherence to product specifications and regulatory requirements. The ideal candidate is a practical, detail-oriented engineer with strong experience in measurement and inspection techniques, who is comfortable working side-by-side with production teams to troubleshoot issues, answer quality-related questions, and drive immediate containment and long-term corrective actions.
What You'll Do:

Provide day-to-day quality support on the manufacturing floor, partnering directly with operators and supervisors to resolve quality issues in real time
Act as a first point of contact for quality-related questions from manufacturing associates, providing guidance on inspection methods, acceptance criteria, and product requirements
Perform and support hands-on inspection and troubleshooting using measurement equipment (e.g., calipers, micrometers, height gauges, optical comparators, CMMs)
Support line clearances, in-process inspections, and real-time disposition of nonconforming material
Monitor manufacturing processes for assigned products, ensuring compliance with Device Master Record (DMR) requirements and accurate completion of Device History Records (DHRs)
Provide guidance on deviations, waivers, and product acceptance decisions, ensuring compliance with regulatory and quality system requirements
Own and drive nonconformance (NCR) activities, including investigation, disposition, root cause analysis, and follow-up for effectiveness
Lead and support root cause investigations on the shop floor, using structured problem-solving methodologies
Partner with Manufacturing Engineering to troubleshoot processes, improve yields, and implement corrective actions
Develop and improve inspection techniques, methods, and procedures to ensure product integrity and compliance to specifications
Write, review, and implement incoming, in-process, and final inspection procedures
Support and/or lead process validations (IQ/OQ/PQ) and capability studies, working closely with cross-functional teams
Apply statistical quality tools (e.g., SPC, Cpk, DOE, hypothesis testing) to assess and improve process capability
Review and provide input on engineering changes, including drawings, BOMs, control plans, FMEAs, and specifications
Contribute to risk management activities (e.g., risk analysis, FMEA updates)
Support internal and external audits, inspections, and regulatory activities as required
Collaborate with suppliers, engineering, and operations teams to resolve quality issues
Own or support CAPA and complaint investigations as needed, including data analysis, technical writing, and implementation of corrective actions

Required Qualifications:

Bachelor's degree in Engineering or related field or 7-10 years of relevant quality engineering experience in a regulated industry
3-5+ years of experience in a regulated manufacturing environment (medical device preferred; aerospace, automotive, or precision manufacturing acceptable)
Strong hands-on experience providing daily support on the manufacturing floor, including operator interaction and real-time troubleshooting
Proven experience with nonconformance management (NCRs), including dispositioning and follow-up for effectiveness
Hands-on experience with measurement and inspection equipment, such as:
Calipers, micrometers, height gauges, Optical comparators, Coordinate Measuring Machines (CMM)
Ability to guide and support operators on inspection techniques and acceptance criteria

Experience with process validation (IQ/OQ/PQ) and capability studies
Working knowledge of applicable quality and regulatory standards, such as: FDA 21 CFR Part 820, ISO 13485, ISO 14971, MDSAP / QSR.
Strong understanding of quality engineering tools:
Root cause analysis / Statistical methods and process capability /
Ability to read and interpret engineering drawings, including GD&T
Strong communication skills and ability to collaborate cross-functionally
Proficiency in Microsoft Office and Minitab

Preferred Qualifications:

Experience in metals, machining, or precision manufacturing environments
Advanced…